人附睾蛋白4与糖类抗原125联合检测在卵巢癌诊断中的应用价值

目的 探讨患者血清人附睾蛋白4(HE4)与糖类抗原125(CA125)联合检测及卵巢恶性风险计算法(ROMA)在卵巢癌诊断中的价值.方法 采用酶联免疫吸附试验(ELISA)检测119例卵巢癌患者(卵巢癌组)、36例交界性卵巢肿瘤(交界性组)、96例卵巢良性肿瘤患者(良性组)及53例女性健康对照者(健康对照组)的血清HE4浓度,同时用电化学发光法检测患者的血清CA125浓度,综合评价HE4与CA125组合的检测效能.结合女性的月经状态,采用ROMA方法计算卵巢癌预测概率(PP),评价PP值的诊断效果.结果 根据受试者工作特性曲线(ROC)分析,HE4的临界值为67.3 pmol/L,灵敏度和特异度分别为80.7%和94.6%.治疗前卵巢癌组患者血清HE4和CA125的中位浓度分别为227.3 pmol/L和444.0 U/ml,与交界性组、良性组和健康对照组差异均有统计学意义(均P＜0.01).手术治疗后,卵巢癌患者的血清HE4和CA125水平明显降低(均P＜0.01).HE4与CA125联合检测时,灵敏度和特异度分别为92.7%和72.5%.未绝经和绝经女性PP值的临界值分别为9.3%和27.3%,诊断未绝经患者的灵敏度和特异度分别为84.6%和77.0%,阳性预测值和阴性预测值分别为70.2%和88.7%;诊断绝经患者的灵敏度和特异度分别为86.3%和77.1%,阳性预测值和阴性预测值分别为94.5%和71.1%.结论 血清HE4是一种良好的血清肿瘤标记物.HE4与CA125联合检测并借助ROMA判定卵巢癌的患病风险有助于提高卵巢癌诊断的准确度.

Abstract：

Objective To investigate the clinical value of combination of human epididymis protein 4 (HE4), CA125 and the Risk of Ovarian Malignancy Algorithm (ROMA) in diagnosis of ovarian carcinoma. Methods To detect the serum concentration of HE4 using ELISA and CA125 using ECL in patients of ovarian carcinoma group (n=119), borderline ovarian tumor group (n=36), benign ovarian neoplasm group (n=96) and female healthy control group (n=53). The ROMA based on the serum level of CA125, HE4 and a woman′s menopausal status was used to calculate the predicted probability (PP) and diagnostic results of ovarian cancers. Results The receiver operating characteristic (ROC) analysis showed the cut-off value was 67.3 pmol/L (the AUC was 0.906, the sensitivity was 80.7% and specificity was 94.6%). The serum levels of HE4 and CA125 in the ovarian carcinoma group were significantly higher than that in the borderline ovarian tumor group, benign ovarian neoplasm group and female healthy control group (P<0.01). The serum levels of CA125 and HE4 showed statistically no significant difference between the borderline ovarian tumor group and benign ovarian neoplasm group (P>0.05). The levels of HE4 and CA125 were reduced significantly in ovarian patients after surgery therapy (P＜0.01). The sensitivity and specificity of HE4 + CA125 combination was 92.7% and 72.5%. The ROMA that can classify patients into high and low risk groups was established as 9.3% in premenopausal and 27.3% in postmenopausal women. Conclusions HE4 is a helpful biomarker for ovarian carcinoma diagnosis. Biomarker combination of HE4 and CA125, and applying of the ROMA are helpful to improve the accuracy in diagnosis of ovarian cancers.

Diagnostic value of combining detection of human epididymis protein 4 and CA125 in patients with malignant ovarian carcinoma

Objective To investigate the clinical value of combination of human epididymis protein 4 (HE4), CA125 and the Risk of Ovarian Malignancy Algorithm (ROMA) in diagnosis of ovarian carcinoma. Methods To detect the serum concentration of HE4 using ELISA and CA125 using ECL in patients of ovarian carcinoma group (n=119), borderline ovarian tumor group (n=36), benign ovarian neoplasm group (n=96) and female healthy control group (n=53). The ROMA based on the serum level of CA125, HE4 and a woman′s menopausal status was used to calculate the predicted probability (PP) and diagnostic results of ovarian cancers. Results The receiver operating characteristic (ROC) analysis showed the cut-off value was 67.3 pmol/L (the AUC was 0.906, the sensitivity was 80.7% and specificity was 94.6%). The serum levels of HE4 and CA125 in the ovarian carcinoma group were significantly higher than that in the borderline ovarian tumor group, benign ovarian neoplasm group and female healthy control group (P<0.01). The serum levels of CA125 and HE4 showed statistically no significant difference between the borderline ovarian tumor group and benign ovarian neoplasm group (P>0.05). The levels of HE4 and CA125 were reduced significantly in ovarian patients after surgery therapy (P＜0.01). The sensitivity and specificity of HE4 + CA125 combination was 92.7% and 72.5%. The ROMA that can classify patients into high and low risk groups was established as 9.3% in premenopausal and 27.3% in postmenopausal women. Conclusions HE4 is a helpful biomarker for ovarian carcinoma diagnosis. Biomarker combination of HE4 and CA125, and applying of the ROMA are helpful to improve the accuracy in diagnosis of ovarian cancers.